In this month’s IRB Corner, we discuss conflicts of interest and research. We define conflicts of interest and explain why it is important to identify all conflicts of interest and develop plans to mitigate or manage these conflicts. We also discuss the researcher’s responsibility to report conflicts of interest to the IRB Office should any occur during a research study.
What are conflicts of interest and why is it important to identify conflicts of interest?
An interest can be seen as a value, goal, or commitment that is held by an individual and is pursued through social interaction (Korenman, 2006). A conflict of interest can occur in the research context when two or more competing or contradictory interests exist. Conflicts of interest can create a situation where the researcher’s judgment, or the integrity of the research, may appear to be compromised. Thus, one reason it is critical for a researcher to identify potential conflicts of interest during a study is for the researcher to implement strategies to mitigate them.
The IRB reviews a study plan listed on the UOPX IRB application with the assumption that research validity is a primary interest. A conflict of interest occurs when a secondary interest, like financial gain, career advancement, personal or professional relationships, investments, gifts, and so on, interferes with the primary interest of conducting a research study with integrity. If conflicts of interest are identified before the study begins, the researcher can outline strategies to address potential conflicts of interest, and thus better manage perceptions of researcher bias, which can negatively impact the validity of the study.
What conflicts of interest must be reported and who needs to know about conflicts of interest?
Any appearance of conflict of interest must be disclosed. The goal of disclosing conflicts of interest is to increase objectivity and reduce bias in research, prevent risk or harm to human subjects, and increase the public trust in research (Night, 2009). Typically, the assessment of the impact of a conflict of interest is best left to those who will use study results. Decisions to disclose conflicts of interest are not left to researchers, as they may be unable to assess the influence of a conflict of interest on their own research. Instead, researchers must report any conflicts of interest or the appearance of a conflict of interest to their Institutional Review Boards (IRBs), professional associations, funding agencies, and journals before reviewing, editing, presenting, or publishing proposals or research (Korenman, 2006).
The UOPX IRB requires its researchers to report their potential conflicts of interest, their interests in commercial success related to the research being conducted, and their relationship to their research on the UOPX IRB application form. Researchers must identify and disclose any competing interests and explain to the IRB how the planned research includes strategies to mitigate potential conflicts of interest. Disclosure of a conflict of interest is completed by submitting a supplemental Conflict of Interest Statement as part of the IRB application. A conflict of interest statement is merely a short explanation of the competing interests with an explanation about how the researcher is managing the conflict of interest with the goal of reducing bias in his or her research. There is not a specific form for a Conflict of Interest Statement; instead, researchers prepare a written statement and upload the statement as a supplemental document as part of their IRB application in IRBNet.
For a more detailed discussion about how a researcher’s relationship to the proposed research might involve a conflict of interest and contribute to potential risk to the human subjects or threaten the integrity of a research study, please see the UOPX GUIDANCE – Relationship to Research document.
All guidance documents, templates, and forms are available in the IRBNet Forms and Templates library, (accessible from the left menu within IRBNet). After reviewing the guidance materials recommended in this article, please contact The University of Phoenix IRB Office at IRB@phoenix.edu if you have a question about conflicts of interest.
Korenman, S. G. (2006). Conflicts of interest (COI) – definitions. In Teaching the responsible conduct of research in humans (chapter 4). Office of Research Integrity. Retrieved from http://ori.hhs.gov/education/products/ucla/chapter4/default.htm.
Night, S. S. (2009). Conflicts of interest and disclosure: A critical assessment of the current COI policy and the value of integrity (PowerPoint slides). Retrieved from http://ori.hhs.gov/sites/default/files/Night.ppt